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Trial registered on ANZCTR


Registration number
ACTRN12623000045617
Ethics application status
Approved
Date submitted
20/10/2022
Date registered
16/01/2023
Date last updated
20/11/2023
Date data sharing statement initially provided
16/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of immune-modulating efficacy of two probiotic strains in healthy adults
Scientific title
The immune response to consuming probiotic strains in healthy adults: a randomised double-blind, placebo-controlled, parallel clinical study
Secondary ID [1] 308232 0
Nil
Universal Trial Number (UTN)
U1111-1284-4968
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
immune health 327990 0
gastrointestinal health 327991 0
Condition category
Condition code
Inflammatory and Immune System 325051 325051 0 0
Normal development and function of the immune system
Oral and Gastrointestinal 325052 325052 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to receive only one of the two probiotic strains or placebo.
These will be delivered in oral capsules, one capsule per day for 4 weeks. Maltodextrin is the excipient.
The capsules will each contain Limosilactobacillus or Lactiplantibacillus strains at a dose of 1 x 10 to the power of 10 CFU.
Adherence to the intervention will be monitored through questionnaire and study product return.
Intervention code [1] 324765 0
Prevention
Comparator / control treatment
The placebo capsules will contain only maltodextrin.
Maltodextrin is the excipient in the treatment capsules
Control group
Placebo

Outcomes
Primary outcome [1] 332873 0
Participant immune status assessed by measuring serum proinflammatory cytokines (interkeukins)
Timepoint [1] 332873 0
Baseline, and 4 weeks after intervention commencement
Secondary outcome [1] 415830 0
Participant immune status assessed by measuring serum T cells
Timepoint [1] 415830 0
Baseline and 4 weeks after intervention commencement
Secondary outcome [2] 415831 0
Bowel function will be measured using the daily bowel habit diary and Bristol Stool Scale
Timepoint [2] 415831 0
Daily for 4 weeks
Secondary outcome [3] 415834 0
Gastrointestinal comfort will be determined weekly using the Gastrointestinal Symptom Rating Scale (GSRS)
Timepoint [3] 415834 0
Weekly for 6 weeks (2 weeks run-in, 4 weeks intervention)
Secondary outcome [4] 415835 0
Changes in appetite and food choices will be determined using weekly 3-day food diary and dietary fructan frequency questionnaires
Timepoint [4] 415835 0
Weekly for 4 weeks of intervention
Secondary outcome [5] 415836 0
Changes in how the participants feel will be measured daily using the Depression, Anxiety, Stress Scale-21 (DASS-21).
Timepoint [5] 415836 0
Daily for 4 weeks of intervention
Secondary outcome [6] 415837 0
Changes in happiness will be measured daily using the Oxford Happiness Questionnaire
Timepoint [6] 415837 0
Daily for 4 weeks of intervention
Secondary outcome [7] 415838 0
Collection of stool samples for measuring markers of gut comfort and health
Timepoint [7] 415838 0
Beginning and end of 4 weeks of the intervention

Eligibility
Key inclusion criteria
Healthy adults 18-50 years at recruitment
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Blood parameters out of normal health ranges; pregnant or breastfeeding, long term chronic illnesses, daily consumption of probiotics, antibiotic treatment at time of study, recent changes in bowel habit, weight loss, blood in stools anal fissures, bleeding hemorrhoids, and family history of gastrointestinal tract cancer or inflammatory bowel disease.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of interventions will be carried out by central randomization by a staff member (biometrician) not interacting with study participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations were performed by an independent biometrician using the Genstat STTEST procedure and data from 2 publications with similar study designs and primary endpoints and comparing the differences between baseline and 4 or 6 weeks of the probiotic interventions. At a 0.05 level of significance, sample sizes of 7, 21 and 28 are required for IL6, IL1B and Il10, respectively (Hepburn et al, 2013), and 9, 6 and 27 for CD8, CD4 and IL10, respectively (Elmadfa et al. 2010) to attain 80% power.
Statistical comparisons between intervention period (4 weeks) and baseline immune marker levels will be performed using an ANOVA model with repeated measures using Genstat or another appropriate statistical package. P values less than 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
8/12/2024
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment outside Australia
Country [1] 25073 0
New Zealand
State/province [1] 25073 0
Manawatu
Country [2] 25074 0
New Zealand
State/province [2] 25074 0
Auckland

Funding & Sponsors
Funding source category [1] 312486 0
Commercial sector/Industry
Name [1] 312486 0
Fonterra Research and Development Centre
Country [1] 312486 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
New Zealand Institute for Plant & Food Research
Address
Batchelar Road, Fitzherbert, Palmerston North 4474
Country
New Zealand
Secondary sponsor category [1] 314077 0
None
Name [1] 314077 0
Address [1] 314077 0
Country [1] 314077 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311826 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 311826 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 311826 0
New Zealand
Date submitted for ethics approval [1] 311826 0
16/01/2023
Approval date [1] 311826 0
15/07/2023
Ethics approval number [1] 311826 0
2023 EXP 17848

Summary
Brief summary
The gastrointestinal tract (GT) is one of the most microbiologically active ecosystems that plays a crucial role in the working of mucosal immune system. Probiotics is a term used to describe beneficial bacteria. The most accepted definition of probiotics was coined by WHO/FAO panel of experts as “live microorganisms that, when administered in appropriate amounts, confer a health benefit on the host”. The most common microorganisms used as probiotics are lactic acid bacteria (LAB), particularly the genus: Lactobacillus spp., Pediococcus spp., and Bifidobacterium spp.
Orally administered probiotic bacteria interact with the intestinal epithelial cells (IECs) or immune cells associated with the lamina propria, through Toll-like receptors, and induce the production of different cytokines or chemokines leading to the activation of the mucosal immune system.
The aim of this study is to assess the impact of two probiotic strains on biomarkers of immunity, bowel habits, stool consistency, wellbeing, and gut comfort in healthy participants.
This is a multi-centre randomised double blind placebo controlled parallel design intervention study involving healthy adult subjects (age 18-50 years) who have volunteered to take part in this study. We aim to recruit 75 volunteers from the general population at both of our study sites in Palmerston North and Auckland. Participants will be randomly allocated into treatment (probiotic 1 and 2) or placebo groups.
A baseline blood sample and stool sample will be collected at day 1 of the study and participants will then consume their allocated daily intervention for 4 weeks (28 days). After 4 weeks of consuming their intervention product, participants will be recalled to the clinical research facility for collection of blood and stool samples. During the 4 weeks of the intervention the participants will complete daily bowel habit, stool consistency, wellness and profile of mood questionnaires, and weekly gut comfort and dietary intake questionnaires.
Blood samples will be analysed for immune markers and stool samples for markers of gut comfort and health.
We hypothesise that probiotics improve human health and wellbeing through immune and gastrointestinal health by enhancing immune responses and intestinal waste elimination.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122506 0
Dr Pramod Gopal
Address 122506 0
Plant & Food Research, Batchelar Road, 4410, Palmerston North
Country 122506 0
New Zealand
Phone 122506 0
+64 6 9537678
Fax 122506 0
Email 122506 0
[email protected]
Contact person for public queries
Name 122507 0
Christine Butts
Address 122507 0
Plant & Food Research, Batchelar Road, 4410, Palmerston North
Country 122507 0
New Zealand
Phone 122507 0
+64 6 3556147
Fax 122507 0
Email 122507 0
[email protected]
Contact person for scientific queries
Name 122508 0
Pramod Gopal
Address 122508 0
Plant & Food Research, Batchelar Road 4410, Palmerston North
Country 122508 0
New Zealand
Phone 122508 0
+64 6 9537678
Fax 122508 0
Email 122508 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.